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Intestinal Parasites in Inhabitants of Kuyavian-Pomeranian Province in Poland

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03490435
Recruitment Status : Completed
First Posted : April 6, 2018
Last Update Posted : March 26, 2020
Information provided by (Responsible Party):
Paweł Sutkowy, Nicolaus Copernicus University

Brief Summary:
The goal of the proposed study is to assess the prevalence of intestinal parasitic diseases in adults and children. These invasions are included to "dirty hand diseases" (per os invasions), therefore it applies mainly preschool children.

Condition or disease Intervention/treatment
Intestinal Disease, Parasitic Chronic Disease Diagnostic Test: Tests for diagnosis of intestinal parasitic diseases

Detailed Description:

It is estimated that 75% of the world's population is infected with parasites and although parasitic diseases are mostly observed in the poor tropical and subtropical countries, there are also many diseases caused by parasites in Poland. In Poland, particular attention is paid to the following parasitic diseases closely related to the digestive system: giardiasis, taeniasis (including cysticercosis), ascariasis, cryptosporidiosis, toxoplasmosis, trichinosis, echinococcosis.

Symptoms of such invasions may include: allergic rhinitis of unknown origin, chronic fatigue or food intolerance. Moreover, many of them are asymptotic, therefore the study group will consist of both healthy people and individuals with undiagnosed diseases or/and chronic symptoms.

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Study Type : Observational
Actual Enrollment : 22 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnostics of Intestinal Parasitosis in Inhabitants of Kuyavian-Pomeranian Province in Poland
Actual Study Start Date : February 17, 2018
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

Group/Cohort Intervention/treatment
Study participants
Both healthy and ailing individuals, both sex, including adults and children.
Diagnostic Test: Tests for diagnosis of intestinal parasitic diseases

Feces testing:

  1. fresh fecal samples will be used to preparing direct (saline and iodine wet) mounts using supplementary techniques (flotation, sedimentation), as well as temporary mounts (hematoxylin and trichrome staining). Other technique of fresh fecal samples examination will be ParaSys™
  2. A non-preserved stool samples will be stored below -20°C. Defrosted fecal specimen will be subjected to enzyme-linked immunosorbent assays (ELISA) - Giardia antigen test (coproantigens)

Primary Outcome Measures :
  1. Intestinal parasites [ Time Frame: 1 day (single evaluation of current samples) ]
    The fecal samples will be assessed qualitavely in terms of life forms of parasites present in human intestine, i.e.: eggs and larvas of flukes, tapeworms and nematodes, as well as protozoa trophozoites and cysts.

  2. Giardia antigen test [ Time Frame: 1 day (single evalutaion of all samples through study completion) ]
    Stool test for Giardia lamblia antigen (ELISA kit)

Biospecimen Retention:   Samples With DNA

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy people and inviduals with undiagnosed diseases or/and chronic symptoms such as: hay fever, skin and food allergies or eg. chronic fatigue.

Inclusion Criteria:

  • healthy and ailing individuals
  • men and females
  • adults and children

Exclusion Criteria:

  • the participants were not be: incapacitated persons, soldiers, prisoners and persons dependent in any way from the investigators

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03490435

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The Chair of Medical Biology, Collegium Medicum of Nicolaus Copernicus University
Bydgoszcz, Kujawsko-Pomorskie, Poland, 85-092
Sponsors and Collaborators
Nicolaus Copernicus University
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Principal Investigator: Paweł Sutkowy, PhD Nicolaus Copernicus Univeristy

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Responsible Party: Paweł Sutkowy, Assistant professor, Nicolaus Copernicus University Identifier: NCT03490435    
Other Study ID Numbers: KB 765/2016
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paweł Sutkowy, Nicolaus Copernicus University:
Per os invasions
Additional relevant MeSH terms:
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Intestinal Diseases, Parasitic
Intestinal Diseases
Chronic Disease
Parasitic Diseases
Disease Attributes
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases